The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Cardioscan - Tm Being Applied For.
| Device ID | K841263 |
| 510k Number | K841263 |
| Device Name: | CARDIOSCAN - TM BEING APPLIED FOR |
| Classification | Echocardiograph |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | Joseph L Watson |
| Correspondent | Joseph L Watson INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-26 |
| Decision Date | 1984-10-19 |